BURGESS TWEAKING ‘CURES’’ INTEROPERABLITY LANGUAGE: The much-anticipated interoperability section of the 21st Century Cures Act is still “in flux” with “a lot of negotiations” ongoing, its author Rep. Mike Burgess tells David Pittman. Burgess said Wednesday that his staff will have the bill rewritten by the time the 21st Century Cures Act hits the House floor later this month. “We’ve been working non-stop since last week, and there are a lot of people who are involved,” the Texas Republican said. “We’re trying to manage the expectations, the fears as best we can.” Despite the Cures bill’s unanimous May 21 approval by the House Energy and Commerce Committee, critics were skeptical of language in Burgess’s section that sunsets the ONC’s Health IT Standards Committee and creates a new, powerful standards-setting body, as well as its broad definition of interoperability, and the dramatic penalties it imposes for “information blocking.” “There are some things that I would attribute to being strong positives because we have gotten some attention from people, but at the same time, we are not finished,” Burgess said. “Our work needs to be concluded before we can say success or lack of success.”

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— When asked about barriers to interoperability not addressed in the 43-page bill — like the creation of a national patient identifier, Burgess said: “I don’t think you’re going to see a lot of substantive changes in the bill. Right now, we’re focused on functionality rather than those intricate details that you mentioned.” He added he was aware of the Senate HELP Committee’s work on legislation with a similar goal, but hadn’t had discussions with the committee. “I’m glad they’re involved,” Burgess said. “We’ll be anxiously awaiting what they have to show us.” His goal is to spur interoperability for the betterment of patients and providers, Burgess said. “I wish things would have worked better from the get go with the HITECH Act when it was passed, but for whatever reason, it didn’t,” he said. “I felt obligated to try to see if we couldn’t make things right. That’s what we’re on the pathway to doing.”

TOUGHER DATA PRIVACY RULES NEEDED, SAY SPEAKERS: Speakers at the Health Privacy Summit conference broadcast concern about data privacy rules, which they say are too lax. Deanna Fei and Deborah Peel note that it’s all too easy for employers to sneak peeks at medical records and use them against employees. Fei spoke of her experience involving AOL CEO Tim Armstrong, who argued in an all-hands meeting that their new benefits policy had been driven by the high healthcare costs of “distressed babies” — one of which was Fei’s. The experience, she felt, gave listeners the impression that it was her baby versus their retirement benefits.

— The drumbeat of news about insurer and provider data breaches is also a story of too little protection given to patients, speakers argued in another panel at the conference. Data breaches at these organizations pose a greater risk than the typical credit-card identity theft: they come with the risk of compromised medical identities. Thieves can then run up medical bills, creating greater costs and burdens for the victims. It’s the “ease of monetization” said Bob Gregg, CEO of ID Experts, that drive such theft. People often don’t check their explanations of benefits from insurers, allowing thefts to stretch over long periods of time. Maneesha Mithal of the Division of Privacy and Identity Protection at FTC, said that agency had asked for more authority from Congress to attack the problem, but hadn’t yet met success.

** A message from the IBM and Epic Team: We support the Department of Defense’s commitment to providing trusted care anytime, anywhere to those who serve and their families. That’s why we’re partnering to bring the future of health IT to our military families who deserve the best care our country has to offer. http://bit.ly/1F99WIt **

DOCS ATTACK 21ST CENTURY BILL AS A STEP BACKWARD: Two Harvard Medical School physicians have attacked the 21st Century Cures bill as a piece of industry-shaped legislation that will set back regulation of drugs and devices. “Patients and physicians would not benefit from legislation that instead of catapulting us into the future could actually bring back some of the problems we thought we had left behind in the 20th century,” wrIte Drs. Aaron Kesselheim and Jerry Avorn in the latest New England Journal of Medicine. FDA is already fast and efficient and by enabling shorter and smaller clinical trials, the bill poses risks, they write. It allows HHS to bypass normal regulatory procedures for antibiotics and to avoid informed consent in some trials, without clearly delineating circumstances for such exceptions, they write. It would enable FDA to rely on surrogate measures of safety and efficacy such as biomarkers that in some cases have failed in the past, they add. FDA has long been criticized for lack of rigorous evaluations of medical devices, “but the law would again lower standards.” They conclude that the bill “that could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit.”

RARE FDA IRE AT SOFTWARE VENDOR: FDA is in typically stern form in a recent warning letter revealed this week. What was unusual was the target: a software vendor — Soft Computer Consultants of Clearwater, Fla. FDA has rarely directed letters at software vendors; Epstein Becker Green lawyer Bradley Merrill Thompson recalls “only a few” such warnings. The letter doesn’t detail one somewhat pertinent piece of information: namely, the offending software. FDA refused to elaborate when asked and Soft Computer Consultants did not respond to inquiries. However, the letter suggested a serious problem. It said one of the company’s programs had a tendency to miss opportunities to flag abnormal lab results due to problems with its interface to other software. After discovering the problem, the company — FDA says — didn’t test its other software to see if those programs had the same problems.

BIG NUMBERS: At the Health Privacy Summit, OCR director Jocelyn Samuels said the agency expects to receive 17,000 HIPAA complaints this year. Samuels also elaborated on what the agency might examine with respect to precision medicine — the basics, essentially: how current privacy laws apply, and how to fill in the gaps. “Whether HIPAA is adequate” in categorizing privacy by covered entities, she said, is “something under debate.” Not all healthcare entities are regulated by HIPAA, she noted. (Samuels said she wasn’t speaking for the administration on this issue).

IF CONSUMERS WANT THEIR DATA, WHERE ARE THE CONSUMERS?: That’s what Peter Levin, the former VA chief technology officer, asked at the Health Datapalooza on Wednesday. He pointed out that a petition spearheaded the day before by Farzad Mostashari — part of a campaign to force CMS to maintain a significant patient view, download and transmit requirement in the meaningful use program — had gotten fewer than 500 signatures. “It’s kind of embarrassing,” said Levin, CEO and founder of the health data interface-building company Amida: Getmyhealthdata.org hasn’t gotten off the ground. “Only two groups of citizens download their data frequently,” Levin said — half a million veterans and 800,000 Medicare and Medicaid recipients who use Blue Button (which Levin helped invent).

SPEAKING OF INTEROPERABILITY. WHY WON’T SOMEONE THINK OF THE CHILDREN?: Bryan Sivak, former CTO of HHS, is thinking of interoperability: what if we set a goal to move kids’ vaccination records to schools? The rigmarole of filling out forms, getting the records, risking the ire of school nurses, and so on could be easily avoided by seamless electronic transfer. Sivak wants it done by the next Health Datapalooza. It will be July 10-13, 2016 in National Harbor, for anyone who works best with firm deadlines.

MORE DATA PRIVACY THREATS — YOUR MEDICAL DEVICES: Turns out if you hack a medical device you can use it to get into the broader hospital network, a report from TripX Security details. Often medical devices are connected to the internet or the electronic health records — they may record vital signs, for one example — and therefore provide a tunnel underneath the typical defenses erected by hospitals. http://politico.pro/1Jnzg5a

YOU’RE INVITED: Join members of POLITICO’s eHealth and Health Care teams for the Outside, In: The Future of Wearable Tech Twitter Chat, on Friday at noon. The chat will discuss the growing use of wireless wearable products, examining the challenges of protecting and regulating the flow of personal information in a hacked world. Learn how to participate here: http://politi.co/1KKivRR; and RSVP here: http://bit.ly/osintc.

** A message from the IBM and Epic Team: We support the Department of Defense’s commitment to providing trusted care anytime, anywhere to those who serve and their families. That’s why we’re partnering to bring the future of health IT to our military families who deserve the best care our country has to offer.

Our team brings innovative technology, operational expertise and change management solutions to help the DoD and providers adopt and deliver world-class care to our military families. Doing so would enhance the patient experience across care settings and improve coordination with the VA and private sector providers. Our approach is centered on the patient, improving care coordination, identifying at-risk patients and reducing hospital readmissions. We also have proven performance through our innovations like IBM Watson, which gives clinicians evidence-based analytics and insights that present the best medical treatment options available.

** A message from Johnson & Johnson: Nurses change lives, and that changes everything. Johnson & Johnson has been a proud advocate of nurse professionals for over 120 years. Every day, their creativity, innovation, and healing touch change patients’ lives – and the world. Nurses are the backbone of our healthcare system, and our critical partners on the front lines of care. Throughout history, we’ve seen how nurse-led innovation in patient care has profoundly changed human health and believe supporting and recognizing nurses as leaders and innovators is one of the most effective ways of empowering them as critical change-makers. Today, Johnson & Johnson is working to elevate the visibility and impact of nursing innovation that is changing the trajectory of health for humanity. Visit https://nursing.jnj.com to learn more. Nurses change lives. And that changes everything. **

About The Author : Darius Tahir

Darius Tahir is an eHealth reporter for POLITICO Pro. Before joining POLITICO, Darius worked for Modern Healthcare (where he covered health care technology) and the Gray Sheet (where he covered medical devices and digital health).

Darius graduated from Stanford in 2009 — meaning he absorbed just enough sunshine and tech optimism to develop a fascination.